Gadobutrol

Gadobutrol is a contrast agent with magnetic properties. It is used along with magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA) to make blood vessels, organs, and other non-bony tissues more visible.

Gadobutrol is used to help diagnose certain issues in the brain and spine (central nervous system), the blood vessels of the kidneys, and the heart. Gadobutrol is also used in adults to help diagnose breast cancer and to check how well blood flows through the heart.

Gadobutrol may also be used for reasons not mentioned in this medication guide.

Gadobutrol is given as an infusion into a vein. A healthcare provider will give you this injection.

You will be monitored for a short time to ensure you do not have an allergic reaction.

Gadobutrol can cause a serious condition in people with advanced kidney disease. Before you get gadobutrol, inform your doctor if you have kidney disease or if you are on dialysis. You might not be able to receive gadobutrol. Also, let your doctor know if you have recently received any contrast agents similar to gadobutrol.

Gadobutrol can lead to a serious condition in people with advanced kidney disease. Ask your doctor about your specific risk.

Gadobutrol can remain in your body for months or even years after you get gadobutrol. It is unclear if this could lead to any health issues in people with healthy kidneys. Inform your doctor if you have had multiple scans with a contrast agent, and include the date of your last scan.

You should not receive gadobutrol if you are allergic to it.

Tell your doctor if you have ever experienced:

• any kind of reaction to a contrast agent;
• diabetes;
• high blood pressure;
• asthma, hay fever, food or drug allergies; or
• liver or kidney disease.

Inform your doctor if you are pregnant or breastfeeding.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Some side effects of gadobutrol may happen up to several days after the injection.

Gadobutrol can cause a life-threatening condition in people with advanced kidney disease. Call your doctor right away if you have any symptoms of this condition, such as:

• burning, itching, swelling, scaling, and tightening or hardening of your skin;
• skin redness or discoloration;
• muscle weakness;
• joint stiffness in your arms, hands, legs, or feet;
• pain; or
• tiredness, trouble moving.

Gadobutrol may cause serious side effects. Call your doctor immediately if you have:

• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath;
• a seizure (convulsions); or
• chest pain or pressure, pain spreading to your jaw or shoulder.

Common side effects of gadobutrol may include:

• pain, burning, irritation, or skin changes where the injection was given;
• headache;
• unusual or unpleasant taste in your mouth;
• nausea; or
• dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for CNS Magnetic Resonance Imaging:

0.1 mL/kg body weight (0.1 mmol/kg) IV bolus injectionComments: Administer manually or by power injector at a flow rate of approximately 2 mL/second. Refer to manufacturer product information to determine volume to be administered.Use: Indicated for use with MRI to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system.

Usual Adult Dose for Diagnostic:

0.1 mL/kg body weight (0.1 mmol/kg) IV bolus injectionComments: Administer manually or by power injector at a flow rate of approximately 2 mL/second. Refer to manufacturer product information to determine volume to be administered.Use: Indicated for use with MRI to assess the presence and extent of malignant breast disease.

Usual Pediatric Dose for CNS Magnetic Resonance Imaging:

0.1 mL/kg body weight (0.1 mmol/kg) IV bolus injectionComments: Administer manually or by power injector at a flow rate of approximately 2 mL/second. Refer to manufacturer product information to determine volume to be administered.Use:-Indicated for use with MRI to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system.

In a medical setting, it is unlikely that you will miss a dose.

In a medical setting, an overdose would be handled promptly.

Follow your doctor's instructions regarding any limits on food, drinks, or activities.

Other drugs may affect gadobutrol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.